NCT00578955

Brief Summary

The purpose of this study is to determine if AzaSite Plus is effective and safe for the treatment of blepharoconjunctivitis compared to AzaSite alone and Dexamethasone alone.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
417

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2007

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

November 19, 2021

Status Verified

November 1, 2021

Enrollment Period

10 months

First QC Date

December 19, 2007

Last Update Submit

November 18, 2021

Conditions

Blepharoconjunctivitis

Keywords

Blepharoconjunctivitis, Ophthalmology

Outcome Measures

Primary Outcomes (1)

  • The resolution of the clinical signs and symptoms.

    2 weeks

Secondary Outcomes (1)

  • Bacterial eradication

    2 weeks

Study Arms (3)

1

EXPERIMENTAL
Drug: 1% Azithromycin and 0.1% Dexamethasone

2

ACTIVE COMPARATOR
Drug: 1% Azithromycin

3

ACTIVE COMPARATOR
Drug: 0.1% Dexamethasone

Interventions

1% Azithromycin and 0.1% DexamethasoneDRUG

Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.

Also known as: AzaSite Plus
1
1% AzithromycinDRUG

Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.

Also known as: AzaSite
2
0.1% DexamethasoneDRUG

Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.

Also known as: Dexamethasone
3

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Have a clinical diagnosis of blepharoconjunctivitis
  • Must be willing to discontinue contact lens wear for the duration of the study

You may not qualify if:

  • Have known sensitivity or poor tolerance to any component of the study medications.
  • Have any clinically significant cardiovascular disorders
  • Have any history of liver or kidney disease resulting in persisting dysfunction
  • Have prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

AzithromycinDexamethasone

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic ChemicalsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 21, 2007

Study Start

December 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

November 19, 2021

Record last verified: 2021-11